This publication describes the compressed gas industry’s standard operating procedures (SOP) for changing the grade of liquid oxygen and liquid nitrogen bulk transports from nonmedical service to medical service. The change of grade procedure meets current good manufacturing practice (CGMP) requirements and ensures that containers are suitable to receive medical grade product.
This publication contains the minimum criteria for changing the grade of liquid oxygen and liquid nitrogen bulk transports from nonmedical to medical service. This includes converting bulk transports from:
• nonmedical oxygen to oxygen, USP; and
• nonmedical nitrogen to nitrogen, NF.
This publication does not apply to bulk transports that undergo a change of service from one product to another product such as oxygen to nitrogen, nitrogen to oxygen, etc.
This publication does not apply to nitrous oxide or carbon dioxide change of grade.